//About Our Products: StemShot
About Our Products: StemShot2018-09-20T19:41:09+00:00
Lone Peak Biologics StemShot Regenerative Medicine

StemShot® Allogeneic Umbilical Cord Blood Stem Cells (Highly Purified)

Use of StemShot® and other umbilical cord stem cells is currently one of the most active areas in human regenerative medicine. This is because the umbilical cord blood carries all the necessary nutrients, stem cells, and growth factors to a developing baby throughout the entire nine months of gestation. These characteristics make cord blood stem-cell suspensions of utmost interest in regenerative medicine procedures.

The distinct immunological characteristics of the umbilical cord blood contained in StemShot® give it high utility as an allograft. These cells are not readily recognized by the recipient’s immune system; hence, the body accepts them, rather than rejecting them as foreign, transplanted cells.
There are several reasons for this. Cord blood cells have had little exposure to foreign antigens, so the T and B cells are immunologically naïve. Cord blood is rich in T regulatory cells, which suppress the activation of T and B cells. The StemShot® cord blood suspension also has mesenchymal stromal cells (MSC), as measured by CD90 positive cells. Perhaps the most noteworthy feature of MSCs is their potential to “calm” an overactive immune system. This observation is the basis of experimental MSC treatments for a variety of autoimmune diseases (e.g., type I diabetes, Crohn’s disease, lupus, rheumatoid arthritis) and for Graft Versus Host disease (a serious complication that can occur after hematopoietic stem cell reconstitution) (1, 2, 3).

Lone Peak Biologics StemShot Regenerative Medicine

StemShot® Premium Allogeneic Umbilical Cord Blood Stem Cells (Highly Purified)

Use of StemShot® and other umbilical cord stem cells is currently one of the most active areas in human regenerative medicine. This is because the umbilical cord blood carries all the necessary nutrients, stem cells, and growth factors to a developing baby throughout the entire nine months of gestation. These characteristics make cord blood stem-cell suspensions of utmost interest in regenerative medicine procedures.

The distinct immunological characteristics of the umbilical cord blood contained in StemShot® give it high utility as an allograft. These cells are not readily recognized by the recipient’s immune system; hence, the body accepts them, rather than rejecting them as foreign, transplanted cells.
There are several reasons for this. Cord blood cells have had little exposure to foreign antigens, so the T and B cells are immunologically naïve. Cord blood is rich in T regulatory cells, which suppress the activation of T and B cells. The StemShot® cord blood suspension also has mesenchymal stromal cells (MSC), as measured by CD90 positive cells. Perhaps the most noteworthy feature of MSCs is their potential to “calm” an overactive immune system. This observation is the basis of experimental MSC treatments for a variety of autoimmune diseases (e.g., type I diabetes, Crohn’s disease, lupus, rheumatoid arthritis) and for Graft Versus Host disease (a serious complication that can occur after hematopoietic stem cell reconstitution) (1, 2, 3).

Why StemShot®?

A key element in developing these applications will require describing the stem cell preparation and composition in detail. Surprisingly, only a small minority of clinical studies characterize the stem cells that they used! For example, a meta-analysis by Murray et.al. looked at characterizations of bone marrow aspirate used in the clinic (4). Less than 20% of the studies cited a cell count or characterization. In contrast, StemShot® provides a detailed description of cell viability, identity, and safety testing. In addition, it offers convenience and ease of use. It is easily obtained via overnight shipping, can be stored at -80℃ for up to two years, and is prepared for use in only a few minutes.

High Cell Viability

StemShot® cell suspensions have a very high percentage of live cells, due to their proprietary isolation and cryopreservation methods. The 85% viability greatly exceeds FDA post-thaw guidelines of 70%. Any freezing and thawing process is harsh to living cells, so some cell death is unavoidable (5). The image cytometry demonstrates that 85% of the StemShot® cells survive, and are the appropriate size for mononuclear leukocytes – HSC and MSC (Table 2 and 3).

StemShot®is:

• A rich source of T-Cells
• Uniquely cryopreserved and freeze the cells using a U.S patented, GMP and clinically graded cryopreserved solutions in order to exponentially minimize or potentially eliminate the elements that would damage the cell viability and reduce the cell quantity after thaw the cells before transplantation.
• Intended for homologous use only
• FDA REGISTERED
• HIPAA Registered
• Public Health registered
• Regulated under Federal Code: HCT/Ps 21 CFR 1271.3(c)
• Highly purified in a unique patented process
• Extra purification step that goes above and beyond current market standards
• This process removes all Granulocytes and Immature RBCs
• Precisely and carefully counted using fully automated state of the art equipment(s) (Full quantitative report will be provided per delivery)
• Tested using state-of-the-art Quality Assurance and Quality Control methods (Full reports available upon client’s request – no fees!)
• Aseptically harvested from cord blood in a fully-controlled sterile environment in a certified, fully-equipped Class 100 clean room.
• A rich source of Hematopoietic Stem Cells.
• Delivered in a highly controlled packaging environment due to temperature sensitivity of the product

Donor Eligibility

StemShot® is extensively serologically tested for multiple infectious diseases/agents and is procured from live, healthy donors during childbirth. Human Cord Blood Stem cells are harvested in a certified class 100 cleanroom under aseptic and good manufacture practices. Umbilical Cord Blood Stem cells were obtained by sterile technique from a pre-screened donor. Please refer to our Certificate of Analysis for a list of infectious diseases panel we test each batch of blood. Additionally, donor medical history, physical assessment, and behavior assessment are reviewed by a medical director before the batch release.

Disclaimer: Reference to a clinical trial study does not reflect an endorsement by StemShot® or Lone Peak Biologics. Talk with a trusted healthcare professional before volunteering for a study, or undergoing an experimental treatment.

Disclosure: The flow cytometry analysis was done independently by a third-party reference lab.

Informational References

1. N. H. Riordan, K. Chan, A. M. Marleau, T. E. Ichim, Cord blood in regenerative medicine: do we need immune suppression? J Transl Med 5, 8 (2007).
2. Y. J. Kim, H. E. Broxmeyer, Immune regulatory cells in umbilical cord blood and their potential roles in transplantation tolerance. Crit Rev Oncol Hematol 79, 112-126 (2011).
3. D. J. Prockop, J. Y. Oh, Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation. Mol Ther 20, 14-20 (2012).
4. I. R. Murray et al., Reporting Standards in Clinical Studies Evaluating Bone Marrow Aspirate Concentrate: A Systematic Review. Arthroscopy 34, 1366-1375 (2018).
5. A. Hubel et al., Post thaw characterization of umbilical cord blood: markers of storage lesion.Transfusion 55, 1033-1039 (2015).

Why StemShotⓇ?

A key element in developing these applications will require describing the stem cell preparation and composition in detail. Surprisingly, only a small minority of clinical studies characterize the stem cells that they used! For example, a meta-analysis by Murray et.al. looked at characterizations of bone marrow aspirate used in the clinic (4). Less than 20% of the studies cited a cell count or characterization. In contrast, StemShot® provides a detailed description of cell viability, identity, and safety testing. In addition, it offers convenience and ease of use. It is easily obtained via overnight shipping, can be stored at -80℃ for up to two years, and is prepared for use in only a few minutes.

High Cell Viability

StemShot® cell suspensions have a very high percentage of live cells, due to their proprietary isolation and cryopreservation methods. The 85% viability greatly exceeds FDA post-thaw guidelines of 70%. Any freezing and thawing process is harsh to living cells, so some cell death is unavoidable (5). The image cytometry demonstrates that 85% of the StemShot® cells survive, and are the appropriate size for mononuclear leukocytes – HSC and MSC (Table 2 and 3).

StemShotⓇ is:

• A rich source of T-Cells
• Uniquely cryopreserved and freeze the cells using a U.S patented, GMP and clinically graded cryopreserved solutions in order to exponentially minimize or potentially eliminate the elements that would damage the cell viability and reduce the cell quantity after thaw the cells before transplantation.
• Intended for homologous use only
• FDA REGISTERED
• HIPAA Registered
• Public Health registered
• Regulated under Federal Code: HCT/Ps 21 CFR 1271.3(c)
• Highly purified in a unique patented process
• Extra purification step that goes above and beyond current market standards
• This process removes all Granulocytes and Immature RBCs
• Precisely and carefully counted using fully automated state of the art equipment(s) (Full quantitative report will be provided per delivery)
• Tested using state-of-the-art Quality Assurance and Quality Control methods (Full reports available upon client’s request – no fees!)
• Aseptically harvested from cord blood in a fully-controlled sterile environment in a certified, fully-equipped Class 100 clean room.
• A rich source of Hematopoietic Stem Cells.
• Delivered in a highly controlled packaging environment due to temperature sensitivity of the product

Donor Eligibility

StemShot® is extensively serologically tested for multiple infectious diseases/agents and is procured from live, healthy donors during childbirth. Human Cord Blood Stem cells are harvested in a certified class 100 cleanroom under aseptic and good manufacture practices. Umbilical Cord Blood Stem cells were obtained by sterile technique from a pre-screened donor. Please refer to our Certificate of Analysis for a list of infectious diseases panel we test each batch of blood. Additionally, donor medical history, physical assessment, and behavior assessment are reviewed by a medical director before the batch release.

Disclaimer: Reference to a clinical trial study does not reflect an endorsement by StemShot® or Lone Peak Biologics. Talk with a trusted healthcare professional before volunteering for a study, or undergoing an experimental treatment.

Disclosure: The flow cytometry analysis was done independently by a third-party reference lab.

Informational References

1. N. H. Riordan, K. Chan, A. M. Marleau, T. E. Ichim, Cord blood in regenerative medicine: do we need immune suppression? J Transl Med 5, 8 (2007).
2. Y. J. Kim, H. E. Broxmeyer, Immune regulatory cells in umbilical cord blood and their potential roles in transplantation tolerance. Crit Rev Oncol Hematol 79, 112-126 (2011).
3. D. J. Prockop, J. Y. Oh, Mesenchymal stem/stromal cells (MSCs): role as guardians of inflammation. Mol Ther 20, 14-20 (2012).
4. I. R. Murray et al., Reporting Standards in Clinical Studies Evaluating Bone Marrow Aspirate Concentrate: A Systematic Review. Arthroscopy 34, 1366-1375 (2018).
5. A. Hubel et al., Post thaw characterization of umbilical cord blood: markers of storage lesion.Transfusion 55, 1033-1039 (2015).

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